NDC 55505-189

Safetussin DM

Dextromethorphan Guaifenesin

Safetussin DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Kramer Laboratories. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

• Product ID: 55505-189_8d0b133f-c65b-4bd8-a09e-2616830cdafc
• NDC: 55505-189
• Product Type: Human Otc Drug
• Proprietary Name: Safetussin DM
• Generic Name: Dextromethorphan Guaifenesin
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Kramer Laboratories
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
• Active Ingredient Strength: 10 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 55505-189-36

237 mL in 1 BOTTLE, PLASTIC (55505-189-36)

• Marketing Start Date: 2015-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55505-189-36 [55505018936]

Safetussin DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-07-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL

OpenFDA Data

• SPL SET ID: 93512e2b-6072-49d2-849e-0a0af0ec9d44
• Manufacturer:
  • Kramer Laboratories
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1050511
  • 996520
• UPC Code:
  • 0053076189360

NDC Crossover Matching brand name "Safetussin DM" or generic name "Dextromethorphan Guaifenesin"

NDC	Brand Name	Generic Name
55505-111	Safetussin DM	Safetussin DM
0295-1111	Safetussin DM	Safetussin DM
69822-201	AKIN DM	DEXTROMETHORPHAN GUAIFENESIN
55505-189	Safetussin	Dextromethorphan Guaifenesin